Enhanced formulations of lamotrigine
AssigneeSupernus Pharmaceuticals, Inc.
InventorsArgaw KIDANE, Kevin Edwards, Padmanabh P. Bhatt
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Abstract
A once-a-day, extended-release formulation of lamotrigine, exhibiting a significantly similar release rate throughout the GI tract irrespective of the pH of the environment, is provided. The formulation comprises lamotrigine, an organic acid, a release enhancing polymer and a release controlling polymer. The use of the formulation for the treatment of the neurological disorders is also disclosed.
Claims43
A pharmaceutical formulation of lamotrigine comprising lamotrigine or salts thereof admixed with a release-equalizing composition comprising a pharmaceutically acceptable organic acid and a release-enhancing polymer, said formulation exhibiting a significantly similar rate of release with a similarity factor of at least 50 throughout the GI tract.
An extended-release formulation of lamotrigine exhibiting a significantly similar release rate with a similarity factor of at least 50 throughout the GI tract irrespective of the pH of the environment, said formulation comprising lamotrigine or salts thereof, a release-equalizing composition, and a release-controlling polymer.
An oral dosage form comprising a formulation of lamotrigine exhibiting a significantly similar release rate with a similarity factor of at least 50 throughout the GI tract.
A method of treatment of a neurological disorder in a mammalian subject comprising administering to said subject a formulation of lamotrigine exhibiting a significantly similar release rate with a similarity factor of at least 50 throughout the GI tract irrespective of the pH of the environment.
An extended-release formulation of lamotrigine that exhibits a significantly similar release rate with a similarity factor of at least 50 throughout the GI tract irrespective of the pH of the environment, said formulation comprising a therapeutically effective amount of lamotrigine or salts thereof, fumaric acid, Eudragit L100-55, and polyethylene oxide, admixed together and forming a matrix.
Dependencies are inferred from the claim text.